Breast Cancer Clinical Trial

Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

Summary

Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).

View Full Description

Full Description

Avelumab is a human immunoglobulin (Ig)G1 monoclonal antibody (mAb) directed against programmed death ligand 1 (PD L1). Avelumab selectively binds to PD L1 and competitively blocks its interaction with programmed death receptor 1 (PD 1), thereby interfering with this key immune checkpoint inhibition pathway. Avelumab is currently being investigated as single agent and in combination with other anti cancer therapies in patients with locally advanced or metastatic solid tumors and various hematological malignancies.

Talazoparib is a potent, orally bioavailable poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor, which is cytotoxic to human cancer cell lines harboring gene mutations that compromise deoxyribonucleic acid (DNA) repair, an effect referred to as synthetic lethality, and by trapping PARP protein on DNA thereby preventing DNA repair, replication, and transcription.

Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent in adult patients with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC, CRPC, and other advanced solid tumors with a BRCA or ATM gene defect
Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor biopsy during the screening period.
Minimum age in Japan is 20 years.
ECOG performance status 0 or 1.
Resolved acute effects of prior therapy
Adequate bone marrow, renal, and liver function.
Negative serum pregnancy test at screening.
Pregnant, breastfeeding females or female patients able to have children must agree to use highly effective method of contraception throughout the study and for at least 30 days after the last dose of avelumab and for at least 7 months after the last dose of talazoparib; fertile male patients must use a condom during treatment and for at least 4 months after the last dose of talazoparib.
Signed and dated informed consent.

Exclusion Criteria:

Prior treatment with a PARP inhibitor.
Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, OX 40, GITR, LAG 3, IDO, TDO,TIM 3, CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. Prior treatment with Sipuleucel-T for patients with mCRPC is allowed. For cohort A2 NSCLC patients prior treatment with anti-PD-1/L1 is allowed
Prior anti-cancer therapy within 2 weeks prior to study enrollment. Prior radiation therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 2 days prior to study enrollment and no clinically significant toxicities are expected (eg, mucositis, esophagitis).
Major surgery within 4 weeks prior to study enrollment.
Current use of immunosuppressive medication at the time of study enrollment.
Known prior or suspected hypersensitivity to investigational products.
Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
Prior organ transplantation including allogenic stem-cell transplantation.
Vaccination within 4 weeks of study enrollment and while on trial is prohibited except for administration of inactivated vaccines.
Diagnosis of Myelodysplastic Syndrome.
Patients with known brain metastases requiring steroids.
Participation in other studies involving investigational drug(s) within 4 weeks prior to study participation and/or during study participation.
Persisting toxicity related to prior therapy >Grade 1
Known HIV or AIDs-related illness.
Positive HBV or HCV test indicating acute or chronic infection.
Active infection requiring systemic therapy.
Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study entry; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
Current or anticipated use within 7 days prior to first dose of study drug, or anticipated use during the study of a strong P-gp inhibitor.
Other acute or chronic medical or psychiatric conditions.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

226

Study ID:

NCT03330405

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 45 Locations for this study

See Locations Near You

Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Highlands Oncology Group
Rogers Arkansas, 72758, United States
Highlands Oncology Group
Springdale Arkansas, 72762, United States
Tower Hematology Oncology Medical Group
Beverly Hills California, 90211, United States
Keck Hospital of USC
Los Angeles California, 90033, United States
LAC+USC Medical Center
Los Angeles California, 90033, United States
USC/Norris Comprehensive Cancer Center/Investigational Drug Services
Los Angeles California, 90033, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
Hoag Memorial Hospital Presbyterian
Newport Beach California, 92663, United States
Freidenrich Center for Translational Research (CTRU)
Palo Alto California, 94304, United States
Stanford Cancer Institute
Stanford California, 94305, United States
Stanford Hospital and Clinics
Stanford California, 94305, United States
Stanford Women's Cancer Center
Stanford California, 94305, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Massachusetts General Hospital (MGH)
Boston Massachusetts, 02114, United States
Massachusetts General Hospital Attn: Svetlana Rashkova
Boston Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute, Attn: Vasilika Koci, PharmD
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
University Of Minesota Health: Clinics And Surgery Center
Minneapolis Minnesota, 55455, United States
University of Minesota Medical Center, Fairview IDS Pharmacy
Minneapolis Minnesota, 55455, United States
University of Minnesota Medical Center, Fairview
Minneapolis Minnesota, 55455, United States
Roswell Park Cancer Center Institute
Buffalo New York, 14263, United States
NYU Investigational Pharmacy
New York New York, 10016, United States
NYU Langone Medical Center
New York New York, 10016, United States
NYU Laura and Isaac Perlmutter Cancer Center
New York New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Mount Sinai Hospital- Pharmacy department
New York New York, 10029, United States
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland Ohio, 44106, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Macquarie University
North Ryde New South Wales, 2109, Australia
Northern Cancer Institute
St. Leonards New South Wales, 2065, Australia
Mater Misericordiae Ltd
Brisbane Queensland, 4101, Australia
Fiona Stanley Hospital
Murdoch Western Australia, 6150, Australia
Institut Jules Bordet
Brussels , 1000, Belgium
Cliniques Universitaires Saint-Luc
Bruxelles , 1200, Belgium
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi , 6000, Belgium
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Phase 1 Unit, Department of Oncology, Section 5073.
Copenhagen , 2100, Denmark
The Experimental Cancer Therapy Unit
Herlev , 2730, Denmark
Orszagos Onkologiai Intezet
Budapest , H-112, Hungary
CRU Hungary Kft.
Miskolc , 3529, Hungary
Pecsi Tudomanyegyetem
Pecs , H-762, Hungary
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Medical Radiological Research Center n.a. A.F. Tsyba -
Obninsk Kaluga Region, 24903, Russian Federation
Medical Radiological Research Center n.a. A.F. Tsyba
Obninsk Kaluga Region, 24903, Russian Federation
GBUZ
Chelyabinsk , 45408, Russian Federation
FSBI "National Medical Research Centre of Oncology n.a.
Moscow , 11547, Russian Federation
Budget Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
Omsk , 64401, Russian Federation
State budgetary institution of healthcare of Yaroslavl region "Clinical oncology hospital"
Yaroslavl , 15005, Russian Federation
University College London Hospitals NHS Foundation Trust
London Other, W1T 7, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester , LE1 5, United Kingdom
Freeman Hospital, The Sir Bobby Robson Cancer Trials
Newcastle Upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

226

Study ID:

NCT03330405

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.